Importance Depression is often comorbid in patients with heart failure (HF) and is associated with worse clinical outcomes. However, depression generally goes unrecognized and untreated in this population. Objective To determine whether a blended collaborative care program for treating both HF and depression can improve clinical outcomes more than collaborative care for HF only and physicians' usual care (UC). Design, Setting, and Participants This 3-arm, single-blind, randomized effectiveness trial recruited 756 participants with HF with reduced left ventricular ejection fraction (<45%) from 8 university-based and community hospitals in southwestern Pennsylvania between March 2014 and October 2017 and observed them until November 2018. Participants included 629 who screened positive for depression during hospitalization and 2 weeks postdischarge and 127 randomly sampled participants without depression to facilitate further comparisons. Key analyses were performed November 2018 to March 2019. Interventions Separate physician-supervised nurse teams provided either 12 months of collaborative care for HF and depression ("blended" care) or collaborative care for HF only (enhanced UC [eUC]). Main Outcomes and Measures The primary outcome was mental health-related quality of life (mHRQOL) as measured by the Mental Component Summary of the 12-item Short Form Health Survey (MCS-12). Secondary outcomes included mood, physical function, HF pharmacotherapy use, rehospitalizations, and mortality. Results Of the 756 participants (mean [SD] age, 64.0 [13.0] years; 425 [56%] male), those with depression reported worse mHRQOL, mood, and physical function but were otherwise similar to those without depression (eg, mean left ventricular ejection fraction, 28%). At 12 months, blended care participants reported a 4.47-point improvement on the MCS-12 vs UC (95% CI, 1.65 to 7.28; P = .002), but similar scores as the eUC arm (1.12; 95% CI, -1.15 to 3.40; P = .33). Blended care participants also reported better mood than UC participants (Patient-Reported Outcomes Measurement Information System-Depression effect size, 0.47; 95% CI, 0.28 to 0.67) and eUC participants (0.24; 95% CI, 0.07 to 0.41), but physical function, HF pharmacotherapy use, rehospitalizations, and mortality were similar by both baseline depression and randomization status. Conclusions and Relevance In this randomized clinical trial of patients with HF and depression, telephone-delivered blended collaborative care produced modest improvements in mHRQOL, the primary outcome, on the MCS-12 vs UC but not eUC. Although blended care did not differentially affect rehospitalization and mortality, it improved mood better than eUC and UC and thus may enable organized health care systems to provide effective first-line depression care to medically complex patients. Trial Registration ClinicalTrials.gov Identifier: NCT02044211.

中文翻译：

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混合协作护理对心力衰竭合并抑郁症患者的疗效：一项随机临床试验。

重要性 抑郁症通常与心力衰竭 (HF) 患者共病，并且与较差的临床结果相关。然而，在这个人群中，抑郁症通常得不到承认和治疗。目的 确定用于治疗 HF 和抑郁症的混合协作护理计划是否比仅针对 HF 和医师常规护理 (UC) 的协作护理更能改善临床结果。设计、设置和参与者 这项 3 臂、单盲、随机有效性试验在 2014 年 3 月至 10 月期间从宾夕法尼亚州西南部的 8 所大学和社区医院招募了 756 名左心室射血分数降低 (<45%) 的 HF 参与者2017 年，并一直观察到 2018 年 11 月。参与者包括 629 名在住院期间和出院后 2 周筛查为抑郁症阳性的参与者和 127 名随机抽样的没有抑郁症的参与者，以方便进一步比较。关键分析于 2018 年 11 月至 2019 年 3 月进行。干预 单独的医师监督护士团队为 HF 和抑郁症提供 12 个月的协作护理（“混合”护理）或仅针对 HF 的协作护理（增强型 UC [eUC]）。主要结果和测量 主要结果是心理健康相关的生活质量 (mHRQOL)，由 12 项简短健康调查 (MCS-12) 的心理成分摘要测量。次要结局包括情绪、身体机能、HF 药物治疗的使用、再住院和死亡率。结果 在 756 名参与者中（平均 [SD] 年龄，64.0 [13.0] 岁；425 [56%] 男性），抑郁症患者报告的 mHRQOL、情绪和身体机能较差，但在其他方面与没有抑郁症的患者相似（例如，平均左心室射血分数，28%）。在 12 个月时，混合护理参与者报告 MCS-12 与 UC 相比提高了 4.47 分（95% CI，1.65 至 7.28；P = .002），但与 eUC 组的得分相似（1.12；95% CI，- 1.15 至 3.40；P = .33）。混合护理参与者的情绪也比 UC 参与者（患者报告的结果测量信息系统 - 抑郁效应大小，0.47；95% CI，0.28 至 0.67）和 eUC 参与者（0.24；95% CI，0.07 至 0.41）更好，但身体基线抑郁和随机化状态的功能、HF 药物治疗的使用、再住院和死亡率相似。结论和相关性 在这项针对 HF 和抑郁症患者的随机临床试验中，电话提供的混合协作护理在 mHRQOL（MCS-12 与 UC 而不是 eUC 的主要结果）方面产生了适度的改善。尽管混合护理对再住院和死亡率没有不同的影响，但它比 eUC 和 UC 更好地改善了情绪，因此可能使有组织的医疗保健系统能够为医疗复杂的患者提供有效的一线抑郁症护理。试验注册 ClinicalTrials.gov 标识符：NCT02044211。它比 eUC 和 UC 更好地改善了情绪，因此可以使有组织的医疗保健系统能够为医疗复杂的患者提供有效的一线抑郁症护理。试验注册 ClinicalTrials.gov 标识符：NCT02044211。它比 eUC 和 UC 更好地改善了情绪，因此可以使有组织的医疗保健系统能够为医疗复杂的患者提供有效的一线抑郁症护理。试验注册 ClinicalTrials.gov 标识符：NCT02044211。